Dextenza ophthalmic insert
OCULAR THERAPEUTIX, INC OCUL · Cataract
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Phase 3
Not recorded
Linked trials
1
From ClinicalTrials.gov
Latest FDA action
None on record
From Drugs@FDA
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- OCULAR THERAPEUTIX, INC OCUL Source: Company record for OCULAR THERAPEUTIX, INC (opens in a new tab)
- Indication
- Cataract Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 Current stageFirst trial start 4 Sep 20201 linked trial
- Filed Not yet
- Approved Not yet
The evidence trail loads here.
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Dextenza ophthalmic insert. Editors add each one with its source.
Filed application
No filed application is on record for Dextenza ophthalmic insert. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Dextenza ophthalmic insert.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT04539548ClinicalTrials.gov record for NCT04539548 (opens in a new tab) | A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract | Phase 3 | Completed | 65 (actual) | 21 Dec 2023 (actual) | No |
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
No FDA approvals on record for this drug.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as Dextenza ophthalmic insert.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- ClinicalTrials.gov NCT04539548 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
Record updated .
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